Canada License Amendment - Old Product to New Product

katastic2908

Involved In Discussions
#1
I am hoping someone can provide me with some assistance as I have tried to find the answer myself and come up empty handed.

We currently have a few medical device licenses in Canada and wish to amend one of them to add a new product that is essentially replacing the existing product. There is no significant change from the old product to the new product, same intended use, same everything except it looks a little different. I am getting ready to submit the amendment application and I was wondering what, if any, is the time period from submission of the amendment and our ability to actually sell the product to our distributor.

Can we sell immediately after we submit the amendment or do we need to wait for some sort of approval or acknowledgment from Canada?
 
Elsmar Forum Sponsor

Edward Reesor

Trusted Information Resource
#3
Since the addition to the license is a fax back form, the process should only take a few days. The certificates are issued electronically as well, so the total time is surprisingly fast.

Keep in mind that the actual license number may change, as amended licenses result in a new MDL number for the original device.
 
Thread starter Similar threads Forum Replies Date
R License Amendment - Health Canada Regulations Canada Medical Device Regulations 3
R Medical Device License - CMDCAS certificate release - Health Canada Canada Medical Device Regulations 0
S Medical Device License Renewal (MDL) Period - Health Canada Canada Medical Device Regulations 6
T Health Canada - Device Changes to include in License Renewal Canada Medical Device Regulations 3
A Canadian Address - Do we need an address in Canada for the Canadian license? Canada Medical Device Regulations 2
B Medical Device (Life Support Ventilators) License Application for Canada - Any Tips? Canada Medical Device Regulations 5
M Class II Medical Device License Processing in Canada Other Medical Device Regulations World-Wide 4
D Amendment Class II - Please confirm if the submission is by email (Canada) - Help Canada Medical Device Regulations 0
S Work performed in Canada on US patients using US device Canada Medical Device Regulations 1
R Exporting to Canada and MDSAP Canada Medical Device Regulations 7
M Quality management certification required by Health Canada Canada Medical Device Regulations 3
C New Class III medical device application for Health Canada Canada Medical Device Regulations 6
JoCam MDL in Canada without Canadian Electrical Testing Canada Medical Device Regulations 0
N Medical Device Misclassified by Health Canada Canada Medical Device Regulations 2
N How to look up all Class 1 medical devices on sale in Canada Canada Medical Device Regulations 3
M Informational Health Canada – Drug and medical device highlights 2018: Helping you maintain and improve your health Medical Device and FDA Regulations and Standards News 1
N Selling a class II Medical Device in Canada in Pharmacies Elsmar Xenforo Forum Software Instructions and Help 10
M Informational Health Canada guidance document – Pre-market Requirements for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada – Mandatory reporting requirements for hospitals Medical Device and FDA Regulations and Standards News 0
M Professional Use Medical Software French Labeling for Canada -- Not Considered Medical Device Canada Medical Device Regulations 2
M Informational Health Canada launches consultations to improve the safety of medical devices Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada – Notice: Revisions to the Guidance Document: Management of Applications for Medical Device Licences Medical Device and FDA Regulations and Standards News 0
L Medical Device Accessory - Health Canada guidance / definition on what an accessory is Canada Medical Device Regulations 3
M Informational Health Canada – Fees for Drugs and Medical Devices Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada – Guidance Document: Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada advises Allergan of its intent to suspend its licences for Biocell breast implants as a precautionary measure Medical Device and FDA Regulations and Standards News 0
M Different websites for different markets - FDA, Health Canada or other requirements Medical Information Technology, Medical Software and Health Informatics 4
E Canada Chemicals of Concern - Similiar program for chemicals like the EU Canada Medical Device Regulations 0
M CE/FCC/Industry Canada - Standards required for Certification for a Bluetooth Device CE Marking (Conformité Européene) / CB Scheme 6
M Informational Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada begins release of clinical data Medical Device and FDA Regulations and Standards News 0
M Informational Publication of Draft Health Canada Implementation Guidance for the International Medical Device Regulators Forum Table of Contents Format Medical Device and FDA Regulations and Standards News 0
E How do you identify what standards a country recognizes outside of FDA, EU, Health Canada Other Medical Device Related Standards 1
B MDSAP for OEM products in Canada for in vitro diagnostic test kit to include lancing device Other Medical Device Related Standards 0
S Ways to attract clients - Flyer distribution in Toronto, Canada Service Industry Specific Topics 1
S Health Canada's Action Plan on Medical Devices - 2019 milestones Canada Medical Device Regulations 0
Leandro Need to register Medical Devices in Canada (FDA, HC, CMDCAS...) Canada Medical Device Regulations 3
M Medical Device News Health Canada – Consultation: Pre-market Requirements for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
F Can an individual apply for an MDEL in Canada, as an establishment? Canada Medical Device Regulations 6
M Canada - Registrars that allow e-auditing for ISO 9001? Registrars and Notified Bodies 4
M Medical Device News Health Canada Notice of intent: Strengthening the post-market surveillance and risk management Canada Medical Device Regulations 1
M Medical Device News Health Canada - Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) - Record of Proceedings – January 26, 2018 Canada Medical Device Regulations 0
M Medical Device News Health Canada - Medical Device Single Audit Program (MDSAP) Transition Plan Canada Medical Device Regulations 2
M Medical Device News Health Canada update - Applications for Medical Device Investigational Testing Authorizations Canada Medical Device Regulations 0
K Selling Medical Devices in Canada - Distributor? Private Label? Canada Medical Device Regulations 10
M Medical Device News Health Canada - Proposed Changes - List of Recognized Standards for Medical Devices Canada Medical Device Regulations 3
M MDSAP Transition - Health Canada Website Notice on Apr 13 2018 Canada Medical Device Regulations 1
M Medical Device News Health Canada Update - 05-09-18 - Pilot Device Advice Canada Medical Device Regulations 0
M Medical Device News Health Canada update 28-08-18 - Licensing Requirements for 3D-Printed Devices Canada Medical Device Regulations 0
C Where to buy the latest MHLW, Canada MDR, Brazil medical device regulations Other Medical Device Regulations World-Wide 2

Similar threads

Top Bottom